FDA Grants Breakthrough Device Designation to NET Recovery's tACS Device for Stimulant Use Disorder
核心洞察
NET Recovery (搜索) received FDA Breakthrough Device Designation for its NET Device (搜索) as an aid in reducing psychostimulant use in adults 18 and older with stimulant use disorder (搜索).
The designation covers a proposed new indication spanning cocaine use disorder (搜索) and amphetamine-type or methamphetamine use disorder (搜索), for which no drug is FDA-approved and no device is FDA-cleared.
The NET Device (搜索) is a transcutaneous alternating current stimulator already cleared for managing opioid withdrawal symptoms alongside standard symptomatic medications and other withdrawal therapies.
NET Recovery (搜索) announced on Sept. 23, 2026 that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its NET Device (搜索) as an aid in reducing psychostimulant use in adults 18 and older diagnosed with stimulant use disorder (搜索), including cocaine use disorder (搜索) and amphetamine-type or methamphetamine use disorder (搜索).
The designation applies to a proposed new indication. The NET Device (搜索) is currently cleared by the FDA for the management of opioid withdrawal symptoms in conjunction with standard symptomatic medications and other withdrawal therapies. It is not currently authorized for the treatment of stimulant use disorder (搜索), and that use remains investigational.
An Unmet Need in Stimulant Use Disorder
According to CDC data cited by the company, approximately 4.5 million Americans struggle with both opioid and stimulant use, and stimulant-involved overdose deaths accounted for 59% of U.S. overdose deaths from January 2021 through June 2024. Despite FDA-approved and cleared treatments for opioid use disorder (搜索), no medication is FDA-approved and no medical device is FDA-cleared to treat cocaine or methamphetamine use disorder (搜索).
"There are millions of people suffering without any approved treatment options for stimulant use disorder (搜索), and this Breakthrough Device Designation brings us one step closer to helping change that with a device that does not require the use of drugs," said Joe Winston, CEO and co-founder of NET Recovery (搜索). "Our goal is to fundamentally transform what treatment looks like with the urgency it deserves, because waiting is not an option for those who are seeking help. We're focused on proving that a non-pharmacological approach can deliver real change for people struggling with stimulant use disorder."
Device Mechanism and Regulatory Path
The NET Device (搜索) is a transcutaneous alternating current stimulator, or tACS. The company describes it as a non-pharmacological technology intended to address the addiction crisis.
The Breakthrough Device Designation provides NET Recovery (搜索) expedited FDA review and priority status for future submissions related to the stimulant use indication. It does not change FDA clearance or approval requirements.
NET Recovery (搜索) is designing a pivotal randomized controlled trial intended to support FDA marketing authorization through what the company believes will be the De Novo review pathway. The company has not disclosed trial start dates, enrollment targets or endpoint definitions.